Yoga Nidra for Insomnia and Posttraumatic Stress Symptoms

NCT06888336 | Completed

• 2 other identifiers: 26303/002ZIAMH002962
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized feasibility study is designed to investigate the feasibility of recruitment and delivery of two variations (brief; full) of a virtual Integrative Restoration (iRest) yoga nidra meditation intervention in stressor- or trauma-exposed participants with insomnia and posttraumatic stress symptoms, compared to a waitlist control group. Feasibility will also be examined for data collection (daily sleep diaries and PTSD symptom surveys) and at-home polysomnography (PSG) study completion prior to and following the intervention. Feasibility measures will include study retention and-for the two yoga nidra groups-adherence to study protocol, and acceptability of the intervention will be assessed qualitatively, in semi-structured interviews, and quantitatively, with the Client Satisfaction Questionnaire, following the intervention. Acceptability of the daily surveys will also be assessed quantitatively. Preliminary efficacy of the interventions on the primary treatment outcomes of insomnia and PTSD symptoms and symptom clusters will be assessed. Secondary outcomes include changes in specific sleep architecture assessed in an at-home polysomnogram (sleep stages, including stage N3 percentage, sleep spindles, rapid eye movement (REM) theta, total sleep time, wake after sleep onset time, sleep onset latency, sleep efficiency), daily sleep characteristics (total sleep time, sleep onset latency, wake after sleep onset time, sleep quality), daily PTSD symptoms, and mindfulness. Exploratory outcomes include sleep quality, experiential avoidance, emotion regulation, self-compassion, depression, anxiety, and nightmares.

Conditions

Posttraumatic Stress Disorder (PTSD); Insomnia; Stressor, Psychological; Psychological Trauma

Keywords

randomized controlled trial; meditation; PTSD; insomnia

Outcome Measures

Primary Outcomes (2)

• Feasibility: Participant Retention

  Retention will be quantified as percentage of participants that complete different levels of the acute protocol (i.e. ≤25%, 26-50%, 51-75%, \> 75% of daily questionnaires, and second at-home PSG) and percentage that complete the follow-up questionnaires.

  From baseline to follow-up (Weeks 1-10, Week 10, Week 18)

• Feasibility: Adherence to Yoga Nidra Protocol

  Adherence will be quantified as percentage of participants that complete 1-7 sessions in each week. Also, a measure of 'quality of meditation' (assessed using the PQ-M for each reported meditation) will serve as an additional measure of adherence.

  Throughout treatment (Week 2 to 10)

Secondary Outcomes (8)

• Sleep Characteristics, Assessed in the At-home PSG

  Change from baseline to post-treatment (Week 2; Week 10)

• Daily Sleep Characteristics

  From baseline to end of treatment/waitlist period (Weeks 1 to 10)

• Daily PTSD Symptom Severity

  From baseline to end of treatment/waitlist period (Weeks 1 to 10)

• PTSD Symptoms (PCL-5)

  Change from baseline to end of treatment and follow-up (Week 2; 10; 18)

• Insomnia Symptoms (ISI)

  Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18)

Other Outcomes (12)

• Experiential Avoidance (BEAQ)

  Change from baseline to post-treatment (Week 2; Week 10)

• Nightmare Disorder Symptom Severity (NDI)

  Change from baseline to post-treatment (Week 2; Week 10)

• Sleep Quality (PSQI)

  Change from baseline to post-treatment (Week 2; Week 10)

Study Arms (3)

Yoga nidra (30 minutes each day)

EXPERIMENTAL

Participants will listen to \~30-minute yoga nidra meditation recordings every day for 8 weeks.

Behavioral: Yoga nidra (full)

Yoga nidra (one 30-minute session/week, six 10-minute sessions/week)

EXPERIMENTAL

For 8 weeks, participants will be asked to listen to one \~30-minute yoga nidra meditation recording per week and six \~10-minute meditation recordings per week.

Behavioral: Yoga nidra (brief)

Waitlist Control

NO INTERVENTION

During the intervention period, waitlist participants will not receive an intervention. At the end of Week 10, participants will be randomly assigned to low-dose yoga nidra or high-dose yoga nidra intervention for following the 8-week period.

Interventions

Yoga nidra (full) BEHAVIORAL

The intervention consists of remotely delivered audio recordings (\~30 minute length) of iRest yoga nidra meditation instructions that participants will be asked to listen to daily for 8 weeks, for a total listening time of about 3.5 hours each week. The yoga nidra practices will be in the tradition of iRest. They will include the following sections: intention setting, articulating a heartfelt desire, inner resource, body sensing, breath sensing, emotion and cognition sensing and opposites, welcoming joy, witnessing awareness, and integration. Each week includes an additional brief (\~2-5 minute) introduction to one of the iRest yoga nidra sections. Participants will be asked to lie on a lightly cushioned surface when listening to the practices. Participants are informed that they may opt to listen to the recordings more often but are instructed to listen to the recordings at least once per day.

Also known as: iRest

Yoga nidra (30 minutes each day)

Yoga nidra (brief) BEHAVIORAL

The intervention will consist of remotely delivered audio recordings of yoga nidra meditation instructions. Participants will be asked to listen to one \~30-minute practice and six \~10-minute practices per week (total listening time of \~1.5 hours each week) for 8 weeks. The yoga nidra practices will be in the tradition of iRest. They will include the following sections: intention setting, articulating a heartfelt desire, inner resource, body sensing, breath sensing, emotion and cognition sensing and opposites, welcoming joy, witnessing awareness, and integration. Each week includes an additional brief (2-5 minute) introduction to one of the iRest yoga nidra sections. Participants will be asked to lie on a lightly cushioned surface when listening to the practices. Participants are informed that they may opt to listen to the recordings more than once a day but are instructed to listen to the 30-minute recording once per week and the 10-minute meditations the other 6 days of the week.

Also known as: iRest

Yoga nidra (one 30-minute session/week, six 10-minute sessions/week)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Endorses experiencing at least one lifetime very stressful or traumatic event that still causes distress
• Score of 13 or higher on the 8-item PCL-5
• Scoring 15 or higher on the Insomnia Severity Index, indicating the presence of moderate to severe insomnia
• Being able and willing to listen to online yoga nidra audio recordings that may each be up to 35 minutes long daily for 8 weeks
• Being willing to monitor sleep and PTSD symptoms for 10 weeks
• Normal or corrected to normal hearing and vision
• Fluent in English
• Reliable daily access to the internet
• Between the ages of 18 and 35
• Reliable daily access to the internet
• Willing to refrain from ingesting caffeine, alcohol, and recreational drugs the day of the sleep studies

You may not qualify if:

• History of schizophrenia, psychotic disorder, or bipolar disorder
• Currently receiving or seeking treatment for alcoholism or a substance abuse disorder
• Currently taking part in another study intended to treat poor sleep or posttraumatic stress symptoms
• Current endorsement of suicidality (score of 2 or higher on Item 9 of the BDI-II)
• Self-harmed or attempted suicide within the past 6 months
• Currently receiving treatment for any mental health disorder or sleep disorder
• Current diagnosis of any sleep disorder, excluding insomnia or nightmare disorder
• Currently taking benzodiazepines, nonbenzodiazepine receptor agonists, orexin agonists or antagonists, antiseizure medication, or any medications for sleep or psychiatric indications
• Score of 5 or higher on STOP-BANG Questionnaire (indicating likelihood of moderate to severe obstructive sleep apnea)
• Previous adverse experience with meditation
• Current regular meditative practice (meditating once or more per month)

Sponsors & Collaborators

• University College, London: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University College London

London, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders; Stress, Psychological; Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Sunjeev Kamboj, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the presence of two different yoga nidra groups (high-dose and low-dose) during their participation in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm parallel assignment

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 21, 2025
• Study Start: March 3, 2025
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Anticipated to begin within 18 months of completion of data collection
• Access Criteria: Data will be made available through controlled access with the National Sleep Research Repository (NSRR), which aims to make data available indefinitely.

Locations

GB (1)